Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects were randomized to receive either tositumomab (Anti-B1 Antibody) and iodine I 131 tositumomab (Arm A) or unlabeled tositumomab (Arm B). Subjects randomized to Arm B were allowed to cross over and receive I 131 tositumomab once their disease had progressed as long as they still fulfilled the protocol entry criteria (except for exclusion criterion 12, prior monoclonal antibody therapy) and were human anti-murine antibody (HAMA) negative. Study endpoint assessments of response were conducted by a Masked Independent Randomized Radiographic and Oncologic Review (MIRROR) panel and the Study Investigators' assessments of safety and survival. Subjects who completed at least two years of follow-up in Protocol BEX104515 (formerly Corixa Protocol RIT-II-002) were enrolled in long term follow-up Protocol BEX104526 (formerly Corixa Protocol CCBX001-051), an administrative protocol, for continued radiographic response evaluations and safety evaluations every 6 months for years 3 through 5 post-treatment and annually for years 6 through 10 post-treatment. Subjects in BEX104526 were assessed for survival, disease status, subsequent therapy for NHL, and long-term safety, including the use of thyroid medication, development of hypothyroidism, human anti murine antibody (HAMA), myelodysplastic syndrome, acute myelogenous leukemia, and all other secondary malignancies. Additionally, subjects were followed for the development of any adverse event(s) deemed by the Principal Investigator as being possibly or probably related to a subject's previous treatment with Iodine I-131 tositumomab. Laboratory evaluations consisting of a thyroid stimulating hormone level and a complete blood cell count, with a differential and platelet count, were obtained annually through year 10 post-treatment.
Dosimetric Dose: Subjects received 450 mg of tositumomab IV followed by 5.0 mCi of Iodine I-131 and 35 mg of tositumomab. Following the dosimetric dose, whole body dosimetry was performed on each subject using a total body gamma camera. Whole body anterior and posterior whole body images were obtained at the following timepoints.
For subjects with ≥150,000 platelets/mm3, the recommended dose was the activity of iodine-131 calculated to deliver 75 cGy of total body irradiation; for subjects with NCI Grade 1 thrombocytopenia (platelet counts ≥100,000 but <150,000 platelets/mm3), the recommended dose was the activity of iodine-131 calculated to deliver 65 cGy of total body irradiation.
This is a Phase II randomized, controlled, two-arm, open-label, multicenter study comparing the safety and efficacy of tositumomab and iodine I 131 tositumomab to tositumomab for the treatment of chemotherapy-relapsed or refractory low-grade or transformed low-grade B-cell NHL.
Treatment Arm A: Subject will undergo 2 phases of study. In the first phase, termed "dosimetric dose", subjects will receive tositumomab (450 mg) followed by tositumomab (35 mg) that has been trace labeled with 5mCi) Iodine-131 tositumomab. Whole body gamma camera scans will be obtained on day 0, day 2, 3, or 4, and day 6 or 7 following the dosimetric dose. Using the dosimetric data from three imaging time points, a subject-specific dose of iodine I 131 tositumomab to deliver the desired total body dose of radiotherapy will be calculated. In the second phase of the study, termed "therapeutic dose", subjects will receive unlabeled tositumomab (450mg) followed by iodine tositumomab (35mg) labeled with the subject-specific dose of iodine I-131 to deliver a whole body dose of 75 cGy to subjects. Subjects with platelet counts of 100,001 - 149,999 cells/mm3, will receive 65 cGy and subjects who are obese will be doses based on 137% of their lean body mass. Subjects will be treated with either saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the first infusion of the Iodine-131 tositumomab (i.e., the dosimetric dose) and continuing for 14 days following the last infusion of radiolabeled tositumomab (i.e., the therapeutic dose).
Treatment Arm B: Subjects will receive the same amount of unlabeled tositumomab (450 + 35 mg) administered over the same time-frame as Arm A on the study Days 0 and 7 (the day 7 dose may be delayed but no longer than 14 days after the first dose).
Crossover treatment Arm B: Subjects in Arm B may crossover and receive Iodine-131 tositumomab following progression of their lymphoma if they still fulfill the protocol inclusion exclusion criteria (except exclusion criteria#12) and are HAMA-negative.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label, two-arm, Arm A and Arm B Crossover | Experimental | Arm A Dosimetric Dose: 450 mg of TST infused over 70 minutes (inclusive of a 10-minute flush) immediately followed by 5 milliCurie (mCi) (35 mg) of I-131 TST infused over 30 minutes (inclusive of a 10-minute flush).• Therapeutic Dose: Seven to 14 days after the dosimetric dose, 450 mg of TST infused over 70 minutes (inclusive of a 10-minute flush) immediately followed by a subject-specific mCi activity (35 mg) of I-131 TST to deliver the desired total body dose (TBD) infused over 30 minutes (inclusive of a 10-minute flush). The desired TBD was 65 cGy for subjects with a baseline platelet count of 100,001-149,999 cells/mm3 and 75 cGy for subjects with a baseline platelet count ≥150,000 cells/mm3. Obese subjects (subjects weighing more than 137% of their calculated lean body weight) were dosed based upon 137% of their calculated lean body mass |
|
| Arm B Crossover | Experimental | Arm B Dosimetric Dose: 450 mg of TST infused over 70 minutes (inclusive of a 10-minute flush) immediately followed by 35 mg of TST infused over 30 minutes (inclusive of a 10-minute flush).Therapeutic Dose: Seven to 14 days after the dosimetric dose, 450 mg of TST infused over 70 minutes (inclusive of a 10-minute flush) immediately followed by 35 mg of TST infused over 30 minutes (inclusive of a 10-minute flush). Subjects randomized to Arm B were allowed to cross-over and receive TST/ I-131 TST once their disease had progressed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodine-131 Anti-B1 Antibody Versus Anti-B1 Antibody in Chemotherapy-Relapsed/Refractory Low-Grade or Transformed Low-Grade Non-Hodgkin's Lymphoma (NHL) | Biological | Subjects will be randomized to receive tositumomab and iodine-131 tositumomab (Arm A) or unlabeled tositumomab (Arm B). Subjects randomized to receive unlabeled tositumomab may crossover and receive radiolabeled Iodine-131 tositumomab following progression of their lymphoma. Response in both arms will be assessed at 7 weeks, 13 weeks, and then at 3-monthly intervals for up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With Confirmed Response Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator | Participants receiving Unlabeled TST with progressive disease (defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters [cm] in diameter by radiographic evaluation or >1 cm in diameter by physical examination.) were assessed separately before and after receiving the crossover treatment of I 131 TST for confirmed response, which included participants with CR, CCR, and PR. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator | CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants (Par.) With a Confirmed Complete Response as Assessed by the Masked Independent Randomized Radiology and Oncology Review (MIRROR) Panel |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (Par.) With a Confirmed Response (CR, CCR, or PR) as Assessed by the MIRROR Panel | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Knox SJ, Goris ML, Davis TA, Trisler KD, Saal J, Levy R. Randomized controlled study of Iodine-131 Anti-B1 Antibody vs. unlabeled-Anti-B1 Antibody in subjects with chemotherapy refractory low-grade non-Hodgkin's Lymphoma [abstract]. Int J Radiat Oncol Biol Phys 1997;39(Suppl):326. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 104515 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Participants (par.) received radioimmunotherapy of tositumomab (TST)/Iodine I 131 TST (Arm A) or unlabeled TST (Arm B) in 2 phases: dosimetric and therapeutic dose. Arm B par. were allowed to crossover and receive I 131 TST, if disease progressed. After TST treatment, par. could have entered a Long-Term Follow-Up study (BEX104526; NCT00240591).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TST and Iodine I 131 TST | Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dosimetric and Therapeutic Treatment |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). |
| The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001 |
| Number of Participants With Confirmed Complete Response (CR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator | Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CR. CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With Confirmed Clinical Complete Response (CCR) as Assessed by the Investigator | CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With Confirmed Clinical Complete Response (CCR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator | Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CCR. CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator | CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator | Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CR + CCR. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator | Confirmed PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With Confirmed Partial Response (PR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator | Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST confirmed PR. Confirmed PR is defined as a >=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001 |
| Duration of Response for All Confirmed Responders, Confirmed Complete Responders, and Confirmed Partial Responders | For all participants with CR, CCR, or PR, duration of response was defined as the time from first documented response to first documented progression. All confirmed responders included participants with CR, CCR, and PR, whereas confirmed complete responders included participants with CR and CCR. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| MIRROR Panel Assessments of Duration of Complete Response (Time From the First Documented Response to the First Documented Progression) | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001 |
| MIRROR Panel Assessments of Duration of Confirmed Response (Time From the First Documented Response to the First Documented Progression) | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001 |
| Time to Progression of Disease or Death as Assessed by the Investigator | Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Time to Progression of Disease or Death in Participants Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator | Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| MIRROR Panel Assessed Time to Response (Time From the Date of Enrollment to the First Documented Response (PR, CR, CCR) | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001 |
| MIRROR Panel Assessed Progression-free Survival | Time from the date of enrollment (the date of randomization) to the first documented progression or death. | The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001 |
| Overall Survival | Overall survival is defined as the time from the treatment start date to the date of death by any cause. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With the Indicated Drug-Related (DR) Adverse Events (AEs) Experienced by 3 or More Participants | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Causality of AEs was determined by the investigators as "none," "remote," "possible," "probable," or "highly probable." AEs considered by the investigator as being at least remotely related to the study treatment were considered to be DR AEs. White blood cell (WBC) count and absolute neutrophil count (ANC) were measured as cells per millimeters cubed (mm^3); hemoglobin was measured in grams per deciliter (g/dL). | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With the Indicated Type of Infection | An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With an Infection for Which Anti-infectives Were Administered | Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With the Indicated Grade 3 or Grade 4 AEs Experienced by 3 or More Participants | AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With the Indicated Grade 3 or Grade 4 Drug-related AEs Experienced by 3 or More Participants | AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With the Indicated Primary Cause of Death | Participants were categorized according to their primary cause of death. Deaths due to progressive disease or to another reason ("Other") were not captured as serious adverse events (SAEs) and are thus not included in the SAE module. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With a Time to Death From the Last Dose of Study Drug Less Than or Equal to 30 Days or More Than 30 Days | Time to death from the last dose of study drug is the time from the last dose of study drug administered to the date of death. Deaths due to progressive disease or to another reason ("Other") were not captured as serious adverse events (SAEs) and are thus not included in the SAE module. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug | An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With the Indicated Fatal SAEs Related to Study Drug | An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations | Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values. Hematologic laboratory evaluations included ANC, hemoglobin (Hb), platelets (Plt), and WBC count. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Nadir Values for ANC, a Hematologic Parameter | Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Nadir Values for Hemoglobin, a Hematologic Parameter | Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Nadir Values for the Hematologic Parameters Platelets and WBC Count | Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities | Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities | Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| Time to Human Anti-Murine Antibodies (HAMA) Positivity From the First Dosimetric Dose | Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of human anti-mouse antibodies. | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 104515 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104515 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104515 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104515 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104515 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104515 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Crossover Phase |
|
|
| Long-Term Follow-Up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TST and Iodine I 131 TST | Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| BG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Number | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Confirmed Response Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator | Participants receiving Unlabeled TST with progressive disease (defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters [cm] in diameter by radiographic evaluation or >1 cm in diameter by physical examination.) were assessed separately before and after receiving the crossover treatment of I 131 TST for confirmed response, which included participants with CR, CCR, and PR. | ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator | CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. | ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants (Par.) With a Confirmed Complete Response as Assessed by the Masked Independent Randomized Radiology and Oncology Review (MIRROR) Panel | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed. | Posted | Number | participants | The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Confirmed Complete Response (CR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator | Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CR. CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. | ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Confirmed Clinical Complete Response (CCR) as Assessed by the Investigator | CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. | ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Confirmed Clinical Complete Response (CCR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator | Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CCR. CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. | ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator | CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR. | ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator | Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CR + CCR. | ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator | Confirmed PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions. | ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants (Par.) With a Confirmed Response (CR, CCR, or PR) as Assessed by the MIRROR Panel | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed. | Posted | Number | participants | The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response for All Confirmed Responders, Confirmed Complete Responders, and Confirmed Partial Responders | For all participants with CR, CCR, or PR, duration of response was defined as the time from first documented response to first documented progression. All confirmed responders included participants with CR, CCR, and PR, whereas confirmed complete responders included participants with CR and CCR. | ITT-Exposed Population. Only those participants evaluable for CR, CCR, or PR were analyzed. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MIRROR Panel Assessments of Duration of Complete Response (Time From the First Documented Response to the First Documented Progression) | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed. | Posted | Median | 95% Confidence Interval | months | The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MIRROR Panel Assessments of Duration of Confirmed Response (Time From the First Documented Response to the First Documented Progression) | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed. | Posted | Median | 95% Confidence Interval | months | The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Disease or Death as Assessed by the Investigator | Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. | ITT-Exposed Population. Participants who experienced progression or died (n=36, 33) and participants who were censored (n=6, 3) were analyzed. A censored value indicates that the participant did not have the event of interest. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Disease or Death in Participants Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator | Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. | ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment and those who progressed/died were analyzed. Participants who experienced progression or died (n=18, 17) and participants who were censored (n=1, 2) were analyzed. A censored value indicates that the participant did not have the event of interest. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MIRROR Panel Assessed Time to Response (Time From the Date of Enrollment to the First Documented Response (PR, CR, CCR) | Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). | ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed. | Posted | Median | 95% Confidence Interval | days | The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MIRROR Panel Assessed Progression-free Survival | Time from the date of enrollment (the date of randomization) to the first documented progression or death. | ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed. | Posted | Median | 95% Confidence Interval | months | The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the time from the treatment start date to the date of death by any cause. | ITT-Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Drug-Related (DR) Adverse Events (AEs) Experienced by 3 or More Participants | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Causality of AEs was determined by the investigators as "none," "remote," "possible," "probable," or "highly probable." AEs considered by the investigator as being at least remotely related to the study treatment were considered to be DR AEs. White blood cell (WBC) count and absolute neutrophil count (ANC) were measured as cells per millimeters cubed (mm^3); hemoglobin was measured in grams per deciliter (g/dL). | ITT-Exposed Population. All participants with any drug-related adverse events were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Type of Infection | An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required. | ITT-Exposed Population | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Infection for Which Anti-infectives Were Administered | Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals. | ITT-Exposed Population. Only those participants who had an infection during the study and during the follow-up period were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Grade 3 or Grade 4 AEs Experienced by 3 or More Participants | AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. | ITT-Exposed Population. All participants with any Grade 3 or Grade 4 AEs experienced by 3 or more participants were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Grade 3 or Grade 4 Drug-related AEs Experienced by 3 or More Participants | AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. | ITT-Exposed Population. All participants with any Grade 3 or Grade 4 drug-related AEs experienced by 3 or more participants were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Primary Cause of Death | Participants were categorized according to their primary cause of death. Deaths due to progressive disease or to another reason ("Other") were not captured as serious adverse events (SAEs) and are thus not included in the SAE module. | ITT-Exposed Population. All participants who died by the completion of LTFU were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Time to Death From the Last Dose of Study Drug Less Than or Equal to 30 Days or More Than 30 Days | Time to death from the last dose of study drug is the time from the last dose of study drug administered to the date of death. Deaths due to progressive disease or to another reason ("Other") were not captured as serious adverse events (SAEs) and are thus not included in the SAE module. | ITT-Exposed Population. All participants who died by the completion of LTFU were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug | An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement. | ITT-Exposed Population. All participants who experienced any SAE were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Fatal SAEs Related to Study Drug | An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement. | ITT-Exposed Population. All participants who experienced any fatal SAE were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations | Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values. Hematologic laboratory evaluations included ANC, hemoglobin (Hb), platelets (Plt), and WBC count. | ITT-Exposed Population. All participants with hematological toxicity were evaluated. The numbers analyzed in the category titles reflect the number of participants with the event of interest plus the number of participants who were censored. A censored value indicates that the participant did not have the event of interest. | Posted | Median | Full Range | days | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Nadir Values for ANC, a Hematologic Parameter | Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection. | ITT-Exposed Population. All participants with hematological toxicity were evaluated. | Posted | Median | Full Range | Cells/millimeters cubed (mm^3) | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Confirmed Partial Response (PR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator | Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST confirmed PR. Confirmed PR is defined as a >=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions. | ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed. | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Nadir Values for Hemoglobin, a Hematologic Parameter | Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells. | ITT-Exposed Population | Posted | Median | Full Range | Grams/dL | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Nadir Values for the Hematologic Parameters Platelets and WBC Count | Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells. | ITT-Exposed Population | Posted | Median | Full Range | cells/microliter | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities | Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. | ITT-Exposed Population | Posted | Number | participants | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities | Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. | ITT-Exposed Population. All participants with Grade 3 or Grade 4 hematologic toxicities were analyzed. The "n" in the category titles reflects the number of participants with the indicated Grade 3 or Grade 4 hematologic toxicity. | Posted | Median | Full Range | days | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Human Anti-Murine Antibodies (HAMA) Positivity From the First Dosimetric Dose | Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of human anti-mouse antibodies. | ITT-Exposed Population. Participants who converted from being negative for HAMA at Baseline to being positive for HAMA following treatment were evaluated. | Posted | Mean | Standard Deviation | days | Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526. |
|
Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.
Serious adverse events are reported regardless of causality. Deaths due to progressive disease or to another reason ("Other") were not captured as serious adverse events (SAEs) and are thus not included in the SAE module.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TST and Iodine I 131 TST | Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. | 18 | 42 | 42 | 42 | ||
| EG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. | 6 | 36 | 33 | 36 | ||
| EG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. | 10 | 19 | 19 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant mesenteric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Chronic myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Proteus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Ulcer | General disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA | Systematic Assessment |
| |
| Fat tissue increased | General disorders | MedDRA | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA | Systematic Assessment |
| |
| Infusion site reaction | General disorders | MedDRA | Systematic Assessment |
| |
| Infusion site swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site extravasation | General disorders | MedDRA | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Secretion discharge | General disorders | MedDRA | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Ingrown skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| WBC <2000 cells/mm^3 | Investigations | MedDRA | Systematic Assessment |
| |
| ANC <1000 cells/mm^3 | Investigations | MedDRA | Systematic Assessment |
| |
| Platelets <50000 cells/mm^3 | Investigations | MedDRA | Systematic Assessment |
| |
| Hemoglobin <8.0 g/dL | Investigations | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gingival infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Nipple pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Prostatism | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Death |
|
| Male |
|
| Hispanic |
|
| Asian |
|
| Black |
|
| Other/Unknown |
|
| percentage of participants |
| 22 |
| 2-Sided |
| 95 |
| 9 |
| 36 |
The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator. |
| No |
| Superiority or Other |
Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
|
|
|
|
|
| OG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
|
|
|
|
|
|
|
| OG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
|
Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
|
|
| OG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
|
| OG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
|
|
|
|
|
| OG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
|
|
|
|
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| OG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| Unlabeled TST |
Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| OG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| OG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| OG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
|
|
|
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| Unlabeled TST |
Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|
| OG001 | Unlabeled TST | Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
| OG002 | Unlabeled TST Crossover | Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. |
|
|